Editor's Notes: New drugs in this article refer to
Innovative/improved new chemical drugs / biological products that have never been granted marketing authorization in or outside China;
Original/improved chemical drugs / biological products that have received marketing authorization outside China and are applying for marketing authorization in China;
First generic drugs in China*.
*"First generic drug in China" refers to the first generic drug developed by a Chinese company and approved by China National Medical Products Administration (NMPA) with marketing authorization.
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In August 2022, China NMPA approved 13 new drugs, including 9 chemical drugs and 4 biological products.
1. Boehringer Ingelheim's Empagliflozin Tablets;
2. Suzhou Zelgen Biopharmaceuticals' Donafenib Tosilate Tablets;
3. Beijing Sciecure Pharmaceutical's Compound Amino Acids (19) and Alanyl Glutamine Injection;
4. Jinan Jingsheng Technology's Formoterol Fumarate Solution for Inhalation;
5. Wego Terumo's Peritoneal Dialysis Solution (Lactate-G1.35%);
6. Wego Terumo's Low Calcium Peritoneal Dialysis Solution (Lactate-G1.35%);
7. Xi'an Libang Pharmaceutical's Melphalan Hydrochloride for Injection;
8. Roche's Entrectinib Capsules;
9. Pfizer's Palbociclib Tablets;
10. MSD's Recombinant Human Papillomavirus 9-Valent Vaccine;
11. SinoCellTech's Ripertamab Injection;
12. GenSci's Recombinant Human Growth Hormone Injection;
13. Shanghai Kaimao Biopharmaceutical's Human Interferon γ for Injection.
1. Empagliflozin Tablets
1 | Generic Name | Empagliflozin Tablets |
2 | Brand Name | Jardiance (欧唐静) |
3 | Classification | Class 2.4 chemical drug |
4 | Application Type | New drug application (NDA), import |
5 | Marketing Authorization Holder (MAH) | Boehringer Ingelheim International GmbH |
6 | Approval Date | Aug. 30, 2022 |
7 | Time from Application Acceptance to Approval | 279 days |
8 | Priority Review | Yes |
9 | Target(s) | Sodium/glucose cotransporter 2 (SLC5A2) |
10 | Indication(s) | Previously approved: Indicated ① as a single therapy / ② in combination with metformin hydrochloride / ③ in combination with metformin hydrochloride and sulphonylurea to improve glycemic control combined with diet and exercise for adults having type 2 diabetes mellitus. Limitation of use: Not recommended for treating type 1 diabetes mellitus or diabetic ketoacidosis. Newly approved on Aug. 30, 2022: Indicated for reducing the risks of cardiovascular death and hospitalization for heart failure in adults with heart failure. |
2. Donafenib Tosilate Tablets
1 | Generic Name | Donafenib Tosilate Tablets |
2 | Brand Name | Ze Pu Sheng (泽普生) |
3 | Classification | Class 2.4 chemical drug |
4 | Application Type | NDA |
5 | MAH | Suzhou Zelgen Biopharmaceuticals Co., Ltd. |
6 | Approval Date | Aug. 12, 2022 |
7 | Time from Application Acceptance to Approval | 293 days |
8 | Priority Review | No |
9 | Target(s) | Vascular endothelial growth factor receptor (VEGFR) Serine/threonine-protein kinase B-raf (BRAF) Platelet-derived growth factor receptor (PDGFR) |
10 | Indication(s) | Previously approved: Indicated for treating unresectable hepatocellular carcinoma (HCC) in patients who have not received systemic therapy. Newly approved on Aug. 12, 2022: Indicated for treating radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC) that is locally advanced or metastatic. |
3. Compound Amino Acids (19) and Alanyl Glutamine Injection
1 | Generic Name | Compound Amino Acids (19) and Alanyl Glutamine Injection |
2 | Brand Name | / |
3 | Classification | Class 1.5 chemical drug (according to the former classification system) |
4 | Application Type | NDA |
5 | MAH | Beijing Sciecure Pharmaceutical Co., Ltd. |
6 | Approval Date | Aug 12, 2022 |
7 | Time from Application Acceptance to Approval | 2,268 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | Indicated for providing parental nutrition and amino acid supplement for adult patients when enteral nutrition is infeasible, insufficient, or contraindicated. |
4. Formoterol Fumarate Solution for Inhalation
1 | Generic Name | Formoterol Fumarate Solution for Inhalation |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | Abbreviated new drug application (ANDA) |
5 | MAH | Jinan Jingsheng Technology Co., Ltd. |
6 | Approval Date | Aug. 30, 2022 |
7 | Time from Application Acceptance to Approval | 427 days |
8 | Priority Review | No |
9 | Target(s) | Beta-2 adrenergic receptor (ADRB2) |
10 | Indication(s) | For long-term aerosolized administration (twice daily: morning and evening) in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary diseases (COPDs), including chronic bronchitis and emphysema. |
11 | Notes | First generic drug in China |
5. Peritoneal Dialysis Solution (Lactate-G1.35%)
1 | Generic Name | Peritoneal Dialysis Solution (Lactate-G1.35%) |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA |
5 | MAH | Wego Terumo (Weihai) Medical Products Co., Ltd. |
6 | Approval Date | Aug. 12, 2022 |
7 | Time from Application Acceptance to Approval | 1,323 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | Indicated to be used in peritoneal dialysis for treating chronic kidney failure. |
11 | Notes | First generic drug in China |
6. Low Calcium Peritoneal Dialysis Solution (Lactate-G1.35%)
1 | Generic Name | Low Calcium Peritoneal Dialysis Solution (Lactate-G1.35%) |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA |
5 | MAH | Wego Terumo (Weihai) Medical Products Co., Ltd. |
6 | Approval Date | Aug. 12, 2022 |
7 | Time from Application Acceptance to Approval | 1,332 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | Indicated for peritoneal dialysis to treat chronic kidney failure. |
11 | Notes | First generic drug in China |
7. Melphalan Hydrochloride for Injection
1 | Generic Name | Melphalan Hydrochloride for Injection |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA |
5 | MAH | Xi’an Libang Pharmaceutical Co., Ltd. |
6 | Approval Date | Aug. 30, 2022 |
7 | Time from Application Acceptance to Approval | 1,721 days |
8 | Priority Review | Yes (for rare disease) |
9 | Target(s) | deoxyribonucleic acid (DNA) |
10 | Indication(s) | 1. Indicated as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma; 2. Indicated as an expedient treatment for multiple myeloma patients not suitable for oral treatment. |
11 | Notes | First generic drug in China |
8. Entrectinib Capsules
1 | Generic Name | Entrectinib Capsules |
2 | Brand Name | Rozlytrek (罗圣全) |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Roche Pharma (Schweiz) AG |
6 | Approval Date | Aug. 12, 2022 |
7 | Time from Application Acceptance to Approval | 271 days |
8 | Priority Review | No |
9 | Target(s) | ALK tyrosine kinase receptor (ALK); Ros1 tyrosine kinase receptor; Neurotrophic Receptor Tyrosine Kinase 1 (NTRK1); BDNF/NT-3 growth factors receptor (TrkB); NT-3 growth factor receptor (NTRK3). |
10 | Indication(s) | Indicated for the treatment of adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC). |
9. Palbociclib Tablets
1 | Generic Name | Palbociclib Tablets |
2 | Brand Name | / |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Pfizer Japan Inc. |
6 | Approval Date | Aug. 12, 2022 |
7 | Time from Application Acceptance to Approval | 611 days |
8 | Priority Review | No |
9 | Target(s) | Cyclin-dependent kinase 4 (CDK4); Cyclin-dependent kinase 6 (CDK6). |
10 | Indication(s) | Indicated for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in post-menopausal women. |
10. Recombinant Human Papillomavirus 9-Valent Vaccine
1 | Generic Name | Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine |
2 | Brand Name | GARDASIL 9 (佳达修9) |
3 | Classification | Class 3.1 prophylactic biological product |
4 | Application Type | Biologics License Application (BLA) |
5 | MAH | Merck Sharp & Dohme Corp. |
6 | Approval Date | Aug. 30, 2022 |
7 | Time from Application Acceptance to Approval | 503 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | Indicated for preventing diseases related to human papillomavirus (HPV). The target group was newly approved to expand from females 16-26 years of age to 9-45 years of age. |
11. Ripertamab Injection
1 | Generic Name | Ripertamab Injection |
2 | Brand Name | / |
3 | Classification | Class 2 therapeutic biological product |
4 | Application Type | BLA |
5 | MAH | SinoCellTech Group Ltd. |
6 | Approval Date | Aug. 30, 2022 |
7 | Time from Application Acceptance to Approval | 981 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | In combination with CHOP (cyclophosphamide, hydroxydaunorubicin, oncovin, and prednisone) regime for the treatment of diffuse large B-cell lymphoma. |
12. Recombinant Human Growth Hormone Injection
1 | Generic Name | Recombinant Human Growth Hormone Injection |
2 | Brand Name | Jintropin (赛增) |
3 | Classification | Class 3.2 therapeutic biological product |
4 | Application Type | BLA |
5 | MAH | GeneScience Pharmaceuticals Co., Ltd. (GenSci) |
6 | Approval Date | Aug. 4, 2022 |
7 | Time from Application Acceptance to Approval | 226 days |
8 | Priority Review | Yes (pediatric drug) |
9 | Target(s) | / |
10 | Indication(s) | Previously approved: 1. For treating children with slow growth caused by endogenous growth hormone deficiency. 2. For treating children with short stature caused by Noonan syndrome. 3. For treating children with short stature or growth retardation caused by SHOX deficiency. 4. For treating children with short stature due to achondroplasia. 5. For treating growth disorders in girls due to gonadal dysgenesis (Turner syndrome). 6. For treating Prader-Willi syndrome (PWS). 7. For treating adults with short bowel syndrome who receives nutritional support. 8. For treating growth hormone deficiency due to confirmed hypothalamic-pituitary disease and severe growth hormone deficiency confirmed by two different growth hormone stimulation tests. 9. For treating severe burn. 10. For treating children with short stature who are born small for gestational age (SGA). Newly approved on Aug. 4, 2022: 11. For treating idiopathic short stature (ISS). |
13. Human Interferon γ for Injection
1 | Generic Name | Human Interferon γ for Injection |
2 | Brand Name | Ga Ma (伽马) |
3 | Classification | Class 3.2 therapeutic biological product |
4 | Application Type | BLA |
5 | MAH | Shanghai Kaimao Biopharmaceutical Co., Ltd. |
6 | Approval Date | Aug. 18, 2022 |
7 | Time from Application Acceptance to Approval | 532 days |
8 | Priority Review | Yes (innovative/improved new drug in shortage and with urgent need for preventing major infectious disease or rare disease). |
9 | Target(s) | / |
10 | Indication(s) | Previously approved: 1. For treating rheumatoid arthritis; 2. Hepatic fibrosis; Newly approved on Aug. 18, 2022: 3. Chronic granulomatous disease (CGD). |
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